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REVOLUTION CT (2016-05-12)
- Starting date:
- May 12, 2016
- Posting date:
- May 30, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-58616
Affected products
A. REVOLUTION CT
Reason
GE Healthcare has become aware of a potential safety issue in the Revolution CT patient table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm involving the potential impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injuries have been reported to date related to this issue.
Affected products
A. REVOLUTION CT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5590000
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
Wisconsin
UNITED STATES